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Study supports efficacy of MIS fusion for patients with chronic SIJ pain
Results of this study indicated minimally invasive sacroiliac joint fusion performed with triangular titanium plates in patients with chronic sacroiliac joint pain was safe and effective compared with conservative management for pain relief at 6 months after treatment.
Researchers also found fusion led to reduced disability and improved function and quality of life in patients who underwent surgery vs. conservative management.
For the ongoing, prospective, multicenter, randomized, controlled iFuse Implant System Minimally Invasive Arthrodesis trial, investigators identified 103 adults with chronic disabling sacroiliac joint (SIJ) pain at nine sites from four European countries. They randomly assigned 52 patients to undergo minimally invasive sacroiliac joint fusion with the iFuse Implant System (SI-BONE Inc.) of triangular titanium plates and 51 patients to undergo conservative management (CM).
CM consisted of typical conservative management used in Europe for pelvic girdle pain.
The primary outcome was the change in self-rated VAS low back pain 6 months after treatment or after the last fusion for patients in the operative group who underwent staged, bilateral surgery.
Investigators used the EuroQol-5D-3L to determine quality of life, the Oswestry Disability Index (ODI) to determine disability and the active straight leg raise (ASLR) test, as well as any adverse events to determine SIJ function.
For the 6-month results, mean low back pain improved in the SIJ fusion group and the CM group by 43.3 points and 5.7 points, respectively. The mean ODI improved in both groups by 26 points for patients who underwent SIJ fusion and by 6 points for patients who underwent CM, investigators noted.
According to the results, the patients who underwent SIJ fusion had statistically better results for ALSR, EuroQol-5D-3L, walking distance and satisfaction. Researchers found no difference between the groups in terms of adverse event frequency, although they reported one patients who underwent SIJ fusion developed nerve impingement postoperatively. ‒ by Monica Jaramillo
Disclosures: Sturesson reports he is a paid consultant for SI-BONE. Please see the full study for a list of all other authors’ relevant financial disclosures.
Perspective
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This study adds to the growing body of literature demonstrating the value of surgical treatment of [sacroiliac] SI joint pain. These findings parallel those of the published 6-month and 12-month data from the [Investigation of Sacroiliac Fusion Treatment] INSITE randomized controlled trial. The surgical patients saw statistically significant and clinically significant improvement. The conservative management group did not see clinically significant improvement. The clinical results for the surgical group also parallel the findings from the [Sacroiliac Joint Fusion with iFuse Implant System] SIFI prospective cohort study. This convergence of results based upon patient self-reported outcomes adds further credence to the above noted studies and the similar findings in multiple retrospective cohort studies. These findings appear real and should be accepted.
Reference:
Whang P, et al. Int J Spine Surg. 2015;doi:10.14444/2006.